Frontiers Health 2023: Host of the inaugural Digital Medicine & DTx Global Policy Summit

Frontiers Health returns next month, FH23 taking place in the Italian capital of Rome between Wednesday 8th and Friday 10th November, that latter day especially set aside this year for the first Digital Medicine & DTx Global Policy Summit.

To find out more about this forthcoming exciting conversation taking place at FH23’s venue of Auditorium della Tecnica, pharmaphorum spoke with Alberta Spreafico, Managing Director of Digital Health & Innovation at Healthware Group, as well as DTA Knowledge Partner Lead for DTx Policies in the EU, and Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA).

A partnership for value-added impact on health outcomes

Healthware Group and the DTA recently partnered and back in June this year both launched a website and published a first joint DTx Policy Report, aimed at helping to advance equitable access and adoption of safe and effective digital therapeutics (DTx) and digital medical devices (DMD), establishing, as Molnar told pharmaphorum, “best practices and policy frameworks to enable broad utilisation and adoption of DTx in Europe and globally.”

“The collaboration between DTA and Healthware has been going on for quite a while,” Spreafico explained. “We share the vision of the opportunity and potential of digital health innovations - in particular, software - to make a value-adding impact for health outcomes. Actually, the DTA was born at Frontiers Health in 2017, in Berlin. Since then, I think Healthware and DTA have kept collaborating in various ways to push the ecosystem forwards to enable software as a medical device, as supported by evidence.”

“The challenge is that, with a very real opportunity on the one hand - with evidence growing in terms of the clinical outcomes that these digital therapeutics can have and can help achieve - on the other hand, the challenges are making those digital therapeutics accessible in a sustainable and equitable manner,” Spreafico continued. “Healthware and the DTA really thought it worth joining efforts to analyse how can we help scale that equitable adoption and sustainable capability to bring digital therapeutics to market that are effective and safe.”

The importance of scaling and reimbursement

One key element of enabling such access at scale, of course, is reimbursement, particularly in Europe, but also globally. Therefore, a deep understanding of the different policies and frameworks at work in diverse countries is critical, and identifying converging trends could potentially facilitate scaling best practices across geographies, Spreafico explained.

“That's what we've been working on together and to build that awareness and capabilities, we also build the website, dtxpolicylandscape.org, where we put our first report together, but we'll keep integrating, also, with information from other regions,” she said.

Indeed, the report - “DTx Policy Pathways: The evolving scenario in Europe - Landscape Analysis & Converging Trends” - aims to provide clarity on existing and evolving policies and Health Technology Assessment (HTA) criteria applicable to DTx, identifying converging trends and potential areas of harmonisation and scalability across Europe.

“Different countries are at various levels of coverage,” Molnar explained. “The most important aspect of digital therapeutics right now, to bring them to patients, is the reimbursement landscape. I always hear a lot of complaints about the US healthcare system, which are always justifiable, but as you look to different countries in Europe and APAC, they're also at completely different levels. Trying to navigate how and where you would launch a product is extremely complex. The level of detail in this report allows people to actually start to make a stronger decision about where they would launch their product, so that they can move it into the hands of patients and expand globally, but you have to start at a place that's going to be receptive to your product [and] this is the best resource I've seen to do that.”

A summit seeking cross-country policy potential for digital medicine & DTx

The inaugural Digital Medicine & DTx Global Policy Summit will take place on the final day of FH23, Friday 10th November, uniting subject matter experts, policy makers, and industry leaders from Europe, United States, and APAC – including both Spreafico and Molnar. The focus will be, as discussed here, on best practices and areas of potential cross-country scaling of best practices, harmonisation or mutual recognition in terms of appraisal criteria, access and reimbursement processes, and strategies for systemic integration, adoption, and value generation. But what of resultant actions of such a conversation?

“I think that what we hope to get is, first of all, be able to provide insights and actionable information on what is being put in place in different countries and how that is evolving in this because it's a continuously evolving scenario so that whoever can launch or would like to access a digital therapeutic knows where that is happening,” Spreafico said. “Second, and also very importantly, we'd like these stakeholders to work together to share and be open to the opportunity of discussing possibilities to not only think about within-country frameworks, but maybe possibilities to collaborate.”

On example of this is through mutual recognition approaches or joint evaluations. An increasing number of countries across Europe, as worldwide, have developed or are developing appraisal criteria, access, and reimbursement policies for DTx and the broader Digital Medical Device (DMD) category. While paving new pathways, there is also a patchwork of nomenclatures and approaches being applied and, while some countries are already providing equitable access and fostering systemic uptake of clinically-validated DMDs, others lack fit-for-purpose frameworks – ultimately limiting equitable, scalable, and timely access to clinically-validated DMDs.

“[Joint evaluations would permit] that, in respect of national independency, in certain aspects, maybe pathways, an access to a digital therapeutic in one country can be somewhat recognised in another country,” Spreafico said. “There can be common sets of health technology assessment requirements or appraisal requirements: that would help scale access for patients and it would avoid fragmentation, duplication, and inequities.”

“I look at the conferences that we do with Healthware and Frontiers Health as working sessions for strategic planning,” Molnar joined. “How do we identify gaps? How do we identify barriers and how do we take them down? How do we advance what already exists so that it's more nimble and more broadly allows for a broader level of adoption of digital health?”

Such international awareness and global focus will be evident not only in the course of the Summit’s discussions, but embodied also in the panellists themselves, who apart from Spreafico and Molnar include:

Anh Bourcet (Nguyen), Global Market Access Leader and founder of HAS4P (Health Access Solutions);
Megan Coder, VP of Product & Policy at the Digital medicine Society (DiMe);
Marty Culjat, Global Head of Digital Medicine & Regulatory Innovation at EVERSANA;
Wolfgang Lauer, Head of Division at the Federal Institute for Drugs and Medical Devices;
Emilie Lopes-Fernandes, Program Lead at the DTA;
Kristin Milburn, CMO & MD of Publications, Events & Digital Health at Healthware Group;
Roberta Sarno, Advisor at APACMed;
Rosanna Tarricone, Associate Dean of the SDA Bocconi School of Management - Government, Health, and Non-Profit Division, and Task Force Member & External Advisory Board Chair at EIT Health DMD Taskforce;
Lily Tang, Deputy Director at NHS England and NHS Improvement, UK;
Marco Marchetti, Director HTA Unit, Italian National Agency for Regional Healthcare Services (Agenas), Italy;
N. Izzuna Ghazali, Deputy Director at The Ministry of Health Malaysia;
Louisa Stüwe, Project Director, and Vincent Vercamer, Project Director – Market Access expert, both in the Digital Health Delegation at the French Ministry of Health and Prevention (Ministère de le Santé et de la Prévention).

Beyond the summit: A conference not to be missed

Frontiers Health 2023 is a premier global digital health innovation event strongly focused on digital therapeutics, breakthrough technologies, healthcare transformation, investments, and ecosystem development. Over the course of three days, between 8th and 10th November, it will bring together thought leaders, policy makers, industry players, and innovative companies to discuss in depth - beyond surface level words - the ongoing challenges, strategic trends, and scalable solutions impacting healthcare today.

“It’s a particular moment in time for the digital health ecosystem,” Spreafico noted. “There is some sad news, but it's also a moment where you pick how's it going to evolve and you can play a role on scaling or not. What I'm looking forward to [at FH23 overall] is hearing in these sessions how each stakeholder, from the manufacturers to the policymakers, to the scientists, to the patients are really working to help set the future of healthcare in making it more systemic at scale, inverting that more recent trend.”

“I'm looking forward to understanding things like data portability and streamlining across countries as best as possible, where we can find the commonalities and be as efficient as possible across different countries. For me and the DTA team, we’re really interested in learning what's possible, so that we can help move that type of area forwards,” Molnar concluded.

Whether you’re interested in attending the whole FH23 conference or just the Digital Medicine & DTx Global Policy Summit, it’s not too late to register.